Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 60 years old?
Source: NCT06238934, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Instituto Nacional de Traumatologia e Ortopedia
- Trial code
- NCT06238934
- Record updated
- 2 February 2024
- Original description
Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.Read full original descriptionShow less
Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.
Inclusion: Bilateral knee OA according to the American College of Rheumatology criteria Kellgren-Lawrence ≤ III in both knees Full range of movement (0 a 120°).
Exclusion: history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus> 10° or valgus >15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index >35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) Hip OA > Tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside Rio de Janeiro metropolitan area.